BEUDAMED
    FDA Recall Terminated

    Varian brand 52-leaf Millennium MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    Recall: Z-1091-2012 · Initiated January 16, 2012

    Recall

    Recall Number
    Z-1091-2012
    Event Number
    61074
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 16, 2012
    Posted
    February 23, 2012
    Terminated
    July 26, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian brand 52-leaf Millennium MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    Reason

    When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose.

    Action

    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides recommended actions when planning and treating dynamic fields on the 52 leaf MLCs. Contact the Help Desk at 1-888-827-4265 for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Canada, China, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Singapore, Bahrain, Egypt, Hong Kong, India, Indonesia, Israel, Malaysia, Morocco, Nepal, South Africa, South Korea, Taiwan, Turkey, Ukraine, United Arab Emirates, Japan, Brazil, Chile, Colombia, Mexico, Panama, Venezuela, Saudi Arabia, and Australia.